Summit Therapeutics and its partner Akeso have released updated overall survival data from the Phase 3 HARMONi trial, providing additional information on the performance of their investigational PD-1xVEGF bispecific antibody ivonescimab in Western patients with previously treated EGFR-mutated advanced non-squamous non-small cell lung cancer (NSCLC).
The new analysis, based on a June 2026 data cutoff, showed an overall survival (OS) hazard ratio of 0.76 among the Western subgroup of 165 patients who received ivonescimab in combination with chemotherapy. This corresponds to a 24% reduction in the risk of death compared with chemotherapy alone. The companies did not report the median OS figures and stated that further details, including confidence intervals and median survival data, are planned for presentation at a future medical conference.
The updated result represents a continued improvement from earlier analyses. The Western subgroup recorded an OS hazard ratio of 0.98 at the trial’s primary analysis in April 2025 and 0.84 in a September 2025 update. At the latest follow-up, the Western subgroup’s hazard ratio reached the same level reported for the overall trial population.
The global HARMONi study enrolled 438 patients with EGFR-mutated advanced non-squamous NSCLC whose disease had progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. Participants received either ivonescimab plus chemotherapy or chemotherapy alone.
The latest findings also address questions about whether results observed in China could be replicated in patients from North America and Europe. Data from Chinese participants previously showed an OS hazard ratio of 0.74 at 32.5 months of follow-up. The Western subgroup now shows a hazard ratio of 0.76 at 23.2 months of follow-up. The updated Western subgroup analysis does not bear statistical significance. Previous analyses of the overall trial population also did not achieve statistical significance, with OS hazard ratios of 0.79 at the primary analysis and 0.78 in September 2025.
“The HARMONi results we announced today are a new analysis that was just recently made available to the FDA,” a Summit spokesperson said in a statement. “We think it’s important context for our submission.”
According to Summit, the updated analysis has been submitted to the U.S. Food and Drug Administration as part of the company’s ongoing Biologics License Application review. The application, submitted earlier this year, is the first U.S. filing for both ivonescimab and the PD-1xVEGF class. The FDA’s target action date is Nov. 14, 2026, although the updated submission could potentially be considered a major amendment and extend the review timeline.
Summit has previously argued that the HARMONi trial’s failure to achieve its overall survival endpoint at the primary analysis was influenced by timing rather than treatment effect. The trial incorporated patients from Akeso’s HARMONi-A study in China, while enrollment progressed more slowly in Western regions. As a result, the primary analysis occurred when relatively few deaths had been recorded among Western participants.
Median follow-up in the Western subgroup was 9.2 months at the primary analysis, increased to 13.7 months in the September 2025 update, and reached 23.2 months in the June 2026 analysis. Summit stated that by the latest cutoff, most Western participants had either completed two years of treatment or discontinued therapy.
Attention is also turning to the Phase 3 HARMONi-3 study, which is evaluating ivonescimab as a first-line treatment for metastatic NSCLC. The company has said final progression-free survival and interim overall survival results from that study are expected later this year. Summit stated that there is currently no update regarding the timing of the HARMONi-3 data release.
Summit Therapeutics and Akeso have released updated survival results from the HARMONi clinical trial evaluating ivonescimab in Western patients with advanced non-small cell lung cancer (NSCLC). The new data reinforce the potential of the investigational therapy while providing additional evidence of its clinical performance in a broader patient population.
Summit Announces Updated HARMONi Survival Results
The latest analysis from Summit includes extended follow-up data that further evaluates overall survival, progression-free survival, and long-term clinical outcomes. According to the companies, the updated findings continue to support the therapeutic potential of ivonescimab as a treatment option for patients with advanced NSCLC.
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